BEUDAMED
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    PLUS PIVOT LINK UNIVERSAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120222711·Carbide, cone pointed, finishing bur, non-cutti...

    HI-TORQUE PILOT 200 GUIDEWIRE

    FDA Adverse Event
    Injury ·ABBOTT·Product code DQX·July 23, 2014

    2.4MM CORTEX SCREW, SELF-TAPPING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACUTEVENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 26, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011

    FI80 OPTIFLUX

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE·Product code KDI·March 28, 2008

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·March 1, 2022

    NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 23, 2025

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·March 1, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014